Phase I clinical trial of Zika vaccine to begin next month

Tests, which involve 48 adults, will be randomised and placebo-controlled

April 18, 2017 10:20 pm | Updated April 19, 2017 01:04 am IST - Chennai

Infected mosquitoes can be carriers of the Zika virus.

Infected mosquitoes can be carriers of the Zika virus.

Bharat Biotech International Ltd in Hyderabad will start the Phase I clinical trial of Zika virus vaccine (MR 766) in two centres in India next month.

“We have already got the approval from DCGI [Drug Controller General of India] in March to carry out the Phase I clinical trial,” says Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.

Dose ranges

It will be a randomised, placebo-controlled, double-blind trial involving 48 adults, both men and women (who are not pregnant). Each volunteer will receive two vaccine doses on days 0 [the starting day] and 30 and will be followed-up for a year for both safety and immune response. Three different dose ranges will be tested.

There will be three arms in the trial, and each one will recieve one of the three different dose ranges.

The Phase I is being initiated based on the promising results in animals trials. In the animal trials, two doses of the vaccine made using an African Zika virus strain conferred 100% protection against mortality and disease in mice. The protection was the same when the mice were infected with an Asian and an African Zika strains.

While the viral load was “undetectable” in the case of vaccinated mice, the amount of virus in unvaccinated mice shot up four days after being infected.

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in

Comments

Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.